By Stephen Nakrosis 
 

PTC Therapeurtics, Inc. said Tuesday the U.S. Food and Drug Administration has extended its review of risdiplam, an investigational survival motor neuron splicing modifier for spinal muscular atrophy, following the submission of additional data.

PTC is working with Roche and the SMA Foundation on the SMA program.

PTC said additional data was submitted by Roche, which triggered the extension. The FDA told Roche its team is working to complete their review as quickly as possible, PTC said, adding "The FDA has also indicated to Roche that no substantive review issues have been identified to date."

PTC also said its European Medicine Agency submission remains on track for the middle of this year.

Roche has also submitted applications for approval in Indonesia, Taiwan, Chile, Brazil, South Korea and Russia, and a submission of the filing in China is imminent, PTC said.

 

--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

 

(END) Dow Jones Newswires

April 07, 2020 17:14 ET (21:14 GMT)

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